A Research Study to Treat Patients With Advanced Hepatocellular Carcinoma - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00108953

Purpose

The purpose of this study is to evaluate the safety and efficacy of doxorubicin plus sorafenib versus doxorubicin plus placebo in patients with advanced hepatocellular carcinoma (HCC).

Condition	Intervention	Phase
Carcinoma, Hepatocellular	Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Drug: Doxorubicin/Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Controlled Study of BAY 43-9006 in Combination With Doxorubicin Versus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma.

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Sorafenib Sorafenib tosylate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Time to Progression [ Time Frame: until progression occured ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall Survival [ Time Frame: until death occurred ] [ Designated as safety issue: No ]
Progression Free Survival [ Time Frame: until progression or death occurred ] [ Designated as safety issue: No ]
Overall Best Tumor Response Rate [ Time Frame: achieved during treatment or within 30 days after termination of active therapy ] [ Designated as safety issue: No ]
Time to Symptomatic Progression [ Time Frame: until first documented symptomatic progression defined by FHSI-8 assessment ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: from first objective response to progression ] [ Designated as safety issue: No ]
Time to Response [ Time Frame: from randomization to first objective response ] [ Designated as safety issue: No ]
Overall Disease Control Rate (DCR) [ Time Frame: from randomization to end of treatment plus 30 days ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	April 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sorafenib + Doxorubicin: Experimental "Sorafenib + Doxorubicin" -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)	Drug: Sorafenib (Nexavar, BAY43-9006) plus Doxorubicin Multi kinase inhibitor plus Chemotherapy
Placebo + Doxorubicin: Active Comparator "Placebo + Doxorubicin" -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)	Drug: Doxorubicin/Placebo Chemotherapy plus Placebo

Detailed Description:

In addition to the key secondary outcome parameters the following parameters will be assessed in an exploratory manner: relative TTP, TTSP, RR and overall survival between the 2 study populations.

The possible and potential predictive assays of clinical benefit through an assessment of the correlation between the defined baseline characteristics and key clinical endpoints.

The safety and tolerability will be assessed in the adverse event section. Doxorubicin pharmacokinetics in HCC patients treated with sorafenib versus placebo will be compared and the pharmacokinetic data will be correlated with doxorubicin-related adverse events (i.e., cardiotoxicity)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients who have a life expectancy of at least 12 weeks
Patients with advanced HCC (unresectable, and/or metastatic) which has been histologically or cytologically documented
Patients must have at least one tumor lesion that meets both of the following criteria: 1) can be accurately measured in at least one dimension according to RECIST; 2) has not been previously treated with local therapy
Patients who have received local therapy except chemoembolization, such as surgery, radiation therapy, hepatic arterial embolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of 25% in the size. Local therapy must be completed at least 4 weeks prior to the baseline scan
Patients who have an ECOG performance status of 0, 1, or 2

Exclusion Criteria:

Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to entry is permitted
History of cardiac disease
Serious myocardial dysfunction
Active, clinically serious infections
Known history of HIV infection
Known CNS tumors including metastatic brain disease
Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108953

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35294
United States, California

Palo Alto, California, United States, 94304-1207

San Francisco, California, United States, 94115

Orange, California, United States, 92868-3201

Sylmar, California, United States, 91342

San Francisco, California, United States, 94121

Beverly Hills, California, United States, 90211-1850
United States, Florida

Miami, Florida, United States, 33136
United States, Louisiana

Lafayette, Louisiana, United States, 70506
United States, Minnesota

Minneapolis, Minnesota, United States, 55455
United States, New Jersey

Hackensack, New Jersey, United States, 07601-1991
United States, New York

New York, New York, United States, 10021-6007

Rochester, New York, United States, 14642
United States, Tennessee

Nashville, Tennessee, United States, 37203
United States, Washington

Seattle, Washington, United States, 98101
Argentina

Neuquen, Argentina, Q8300HDH
Argentina, Capital Federal

Buenos Aires, Capital Federal, Argentina, C1264AAA

Buenos Aires, Capital Federal, Argentina, C1280AEB
Canada, Ontario

Toronto, Ontario, Canada, M5G 2M9
China

Hong Kong, China
Russian Federation

Kazan, Russian Federation, 420111

Krasnodar, Russian Federation, 350040

Kirov, Russian Federation, 610002
United Kingdom, Greater London

London, Greater London, United Kingdom, W12 0HS
United Kingdom, Greater Manchester

Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Kent

Maidstone, Kent, United Kingdom, ME16 9QQ
United Kingdom, Merseyside

Bedington, Merseyside, United Kingdom, CH63 4JY
United Kingdom, West Midlands

Birmingham, West Midlands, United Kingdom, B15 2TT

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11546, EudraCT 2004-001770-40
Study First Received:	April 21, 2005
Results First Received:	April 23, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00108953 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Cancer
Liver Cancer
Hepatocellular carcinoma
HCC

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Carcinoma, Hepatocellular
Enzyme Inhibitors
Antibiotics, Antineoplastic
Protein Kinase Inhibitors
Pharmacologic Actions

Doxorubicin
Carcinoma
Liver Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Adenocarcinoma
Sorafenib
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009